Regulatory Compliance
Xodus Quality Management System Certifications
Xodus Medical, Inc. is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations
Notified Body / Registrar/ Certification Body
Xodus Medical, Inc. maintains ISO 13485:2003 certification and is audited for compliance by:
SNCH
2a Kalchesbreck
L-1852 Luxembourg, Luxembourg
Xodus Medical, Inc. maintains CE certification and is audited for compliance by:
SNCH
2a Kalchesbreck
L-1852 Luxembourg, Luxembourg
Xodus Medical, Inc. maintains US FDA 21 CFR 820 and is audited for compliance by:
US FDA
Philadelphia District
Pittsburgh Resident Post
7 Parkway Center, Room 250
Pittsburgh, PA 15220
Authorized European Representative
Emergo Group, Inc., Austin, Texas USA
Telephone: +1-512-327-9997
http://www.EmergoGroup.com/services/usa
Countries Xodus Currently Exports To
Australia, Austria, Brazil, Canada, Chile, Denmark, Emirates, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, South Korea, Switzerland, Thailand, Turkey, United Arab & United Kingdom.
Material Safety Data Sheets
Supplied upon request.
Manufacturer Warnings:
Reuse of single use devices is prohibited due to the risk of cross contamination and/or infection.